NCT06651580Recruiting
Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study
Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
This clinical trial collects blood, saliva, urine, or stool samples to help identify possible genetic mutations that may increase a person's chance at developing pancreatic cancer. Finding genetic markers among pediatric patients with acute recurrent pancreatitis and chronic pancreatitis may help identify patients who are at risk of pancreatic cancer.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1600 (estimated)
- First submitted
- 18 Oct 2024
- Start date
- 1 Apr 2021
- Primary completion date
- 2 Feb 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Pancreatic cancer, Childhood cancers
- NCT number
- NCT06651580
What you commit to
- Study type: Observational
- Planned participants: 1600
- From 1 Apr 2021 to the primary completion date, 2 Feb 2027
- 26 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the subject's ability to tolerate study interventions
Who the study is looking for
- All subjects/parents must sign an informed consent and/or assent indicating that they are aware of the investigational nature of this study
- Subjects/parents must have signed an authorization for the release of their or their child's protected health information
- All children must be under 18 years of age at the time of enrollment
- All children providing samples should fit the ARP or CP inclusion criteria defined below:
- Acute pancreatitis (AP): AP is defined as requiring 2 of the following:
- Abdominal pain compatible with AP
- Serum amylase and/or lipase values \>= 3 times upper limits of normal
- Imaging findings of AP, such as gland enlargement, acute inflammatory changes, and fluid collections
- ARP is defined as: At least 2 episodes of acute pancreatitis with complete resolution of pain and a \>= 1 month pain-free interval between episodes
- Chronic Pancreatitis:
- Children with at least:
- One irreversible structural change in the pancreas with or without abdominal pain +/- exocrine pancreatic insufficiency +/- diabetes
- Irreversible structural changes:
- Ductal calculi, dilated side branches, parenchymal calcifications found in any imaging (abdominal ultrasound \[abd US\], magnetic resonance imaging/magnetic resonance cholangiopancreatography \[MRI/MRCP\], computerized tomography \[CT\], endoscopic retrograde cholangiopancreatography \[ERCP\], endoscopic US \[EUS\])
- Ductal obstruction or stricture/dilatation/irregularities that are persistent (for \>= 2 months) on any imaging
- Parenchymal atrophy, irregular contour, accentuated lobular architecture, cavities alone are not diagnostic findings for CP
- Surgical or pancreatic biopsy specimen demonstrating histopathologic features compatible with CP (acinar atrophy, fibrosis, protein plugs, infiltration with lymphocytes, plasma cells, macrophages)
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sydney Children's Hospital Coordinator of this site? Confirm its status | Randwick | Australia | Recruiting |
| The Montreal Children's Hospital of the MUHC Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Hadassah University Hospital Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Emory University Hospital/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Johns Hopkins University/Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| University of Texas Southwestern/Children's Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Colorado Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| University of Iowa/Holden Comprehensive Cancer Center Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Children's Hospital of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| University of Minnesota/Masonic Children's Hospital Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Ochsner Medical Center Jefferson Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| UCSF Benioff Children's Hospital Oakland Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| Stanford Cancer Institute Palo Alto Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Children's Hospital of Pittsburgh of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Children's Hospital of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.